RecruitingPhase 1Phase 2NCT04261855

Targeted Therapy and Avelumab in Merkel Cell Carcinoma

A Phase Ib/II Study of Combination Avelumab With Peptide Receptor Radionuclide Therapy or Conventional Fractionated Radiotherapy in Patients With Metastatic Merkel Cell Carcinoma


Sponsor

Melanoma and Skin Cancer Trials Limited

Enrollment

19 participants

Start Date

Oct 8, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

10.17 GoTHAM is intended as a signal-seeking, biomarker, phase Ib/II study that will evaluate the safety and anti-tumour activities of the novel combination of avelumab with 177-Lu-DOTATATE (a type of peptide receptor radionuclide therapy; PRRT) or external beam radiation therapy (EBRT) in patients with metastatic Merkel cell carcinoma (mMCC).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing targeted therapy drugs combined with avelumab (an immunotherapy drug) in people with Merkel cell carcinoma — a rare and aggressive type of skin cancer — that has spread to other parts of the body and has not been treated before. **You may be eligible if:** - You are 18 or older with metastatic Merkel cell carcinoma confirmed by biopsy - You have not yet received any systemic (whole-body) therapy for your advanced disease - You have at least one measurable tumor on CT or MRI scans - You are otherwise healthy enough to participate in daily light activities **You may NOT be eligible if:** - You have already received systemic therapy for unresectable or metastatic Merkel cell carcinoma - You have significant organ problems or active autoimmune disease - You are pregnant or not using adequate contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAvelumab

All patients will receive avelumab intravenously (IV) at 10 mg/kg every 2 weeks for 24 months or until unacceptable toxicity or evidence of disease progression

RADIATIONExternal Beam Radiation Therapy (EBRT)

Patients allocated to Arm A will receive EBRT on 2 occasions, 8-10 weeks apart

RADIATIONLutetium-177 (177Lu)-DOTATATE

Patients allocated to Arm B will receive 177-Lu-DOTATATE treatment on 2 occasions, 8-10 weeks apart. This treatment arm is now closed to recruitment.


Locations(10)

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Mid North Coast Cancer Institute - Coffs Harbour Health Campus

Coffs Harbour, New South Wales, Australia

Lake Macquarie Private Hospital

Gateshead, New South Wales, Australia

Gosford Hospital

Gosford, New South Wales, Australia

Wyong Hospital

Hamlyn Terrace, New South Wales, Australia

Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Sir Charles Gaidner Hospital

Perth, Western Australia, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Royal North Shore Hospital

Sydney, New South Wales, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04261855


Related Trials